Empty vials containing a dose of the Johnson & Johnson COVID-19 coronavirus vaccine are on a table as South Africa proceeds with its inoculation campaign at Klerksdorp Hospital on February 18, 2021.
Phill Magakoe | AFP | Getty Images
Two participants in the trial suffered severe allergic reactions shortly after receiving the Johnson & Johnson Covid-19 vaccine, a J&J scientist told an FDA group on Friday.
J&J was first briefed Wednesday on allergic reactions, it told the FDA’s advisory committee on vaccines and biological products related to Macaya Douoguih, head of clinical development and medical affairs for the J&J vaccine division. Janssen.
One of the people was taking part in an ongoing trial in South Africa and developed anaphylaxis, a serious and life-threatening allergic reaction after receiving the vaccine, he said.
He gave no details about the second person’s reaction.
“We will continue to monitor these events closely,” he told the group.
There were previously no reports of anaphylaxis in the J&J clinical trial. Currently, the Centers for Disease Control and Prevention monitors events such as states and pharmacies that present Pfizer and Moderna vaccines.
There have been 46 reports of anaphylaxis in those who received the Pfizer vaccine and 16 cases in those who received the Modern, according to a CDC report released Feb. 16. The agency said the onset of the reaction is in the range of those reported for the flu vaccine.
The CDC asks health care providers to monitor patients 15 minutes after vaccination and 30 minutes for those with a history of allergic reactions.
If someone has a severe allergic reaction after receiving the first dose of Covid-19 vaccine, the CDC recommends that you do not get the second dose, even if the allergic reaction was not severe enough to require attention. emergency.